This part of ISO 7396 includes requirements for supply systems, pipeline distribution systems, control systems, monitoring and alarm systems and non-interchangeability between components of different gas/vacuum systems.

This part of ISO 7396 specifies safety requirements for pipeline systems used in healthcare facilities, both public and private. It applies to all facilities providing healthcare services regardless of type, size, location or range of services, including, but not limited to:

NOTE 3 This part of ISO 7396 may also be used as reference for pipeline systems for medical gases and vacuum intended to be installed in places other than healthcare facilities.

ISO 7396-1:2016 applies to the following different types of oxygen supply systems:

- supply systems in which all sources of supply deliver oxygen; in this case the concentration of the oxygen will be greater than 99%;

- supply systems in which all sources of supply deliver oxygen 93; in this case the concentration of the oxygen may vary between 90% and 96%;

NOTE 4 A mixture of oxygen 93 and oxygen may be delivered by a medical gas supply system. In this case the concentration of the gas can vary between 90% and >99%.

ISO 7396-1:2016 also applies to:

- extensions of existing pipeline distribution systems;

- modifications of existing pipeline distribution systems;

- modifications or replacement of supply systems or sources of supply.

Oxygen concentrators for domiciliary use are excluded from the scope of this part of ISO 7396.

NOTE 5 Requirements for oxygen concentrators for domiciliary use are specified in ISO 80601‑2-69.

(*) EN 14931 defines additional requirements for hyperbaric application, in particular for flows and pressures of compressed air required to pressurize the hyperbaric chamber and to drive other connected services. Also included are requirements for oxygen and other treatment gases administered to patients.

ISO 7396-1:2016 does not apply to vacuum systems intended to be used in dentistry.

ISO 7396-1:2016 does not apply to filling systems for transportable cylinders and transportable cylinder bundle systems.